Product Safety Recalls

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CEFAZOLIN SODIUM Recall D-1117-2022

Description: Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex container, Rx only, MFG: B. Braun Medical Inc., NDC 0264-3103-11

CEFAZOLIN SODIUM Recall D-1117-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1117-2022
Event ID89646
BrandCEFAZOLIN SODIUM
Generic NameCEFAZOLIN SODIUM
ManufacturerCEFAZOLIN SODIUM
Original Package?1
Active SubstanceCEFAZOLIN SODIUM
Drug RouteINTRAVENOUS
DistributionUSA nationwide.
Quantity26 cases
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0264-3103 0264-3105
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierP380M0454Z
Drug Application NumberNDA050779
Structured Product Labeling (SPL ID)77c1e04e-d104-4906-8e80-d77756d9db2f
Structured Product Labeling (SPL Set ID)17f8f038-c204-4dab-80d7-6f7ac41ddbec
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